Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Pivotal trial pits St. Jude Medical’s Amplatzer Amulet anti-stroke device against Boston Scientific’s Watchman
St. Jude Medical said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, which is designed to reduce the risk of stroke in patients with atrial fibrillation.
The Amplatzer Amulet device is designed to occlude the left atrial appendage to prevent the formation of blood clots that could lead to a stroke. The FDA approved a similar device made by Boston Scientific, the Watchman implant, in March 2015; St. Jude’s 1,600-patient IDE trial will compare the Amplatzer Amulet to the Watchman in patients with non-ventricular arrhythmias. Read more
4. Stryker acquires Ivy Sports Medicine and its meniscus repair device
Stryker said today that its endoscopy division acquired Ivy Sports Medicine and its collagen meniscus implant for an undisclosed amount.
Kalamazoo, Mich.-based Stryker touted the Ivy Sports platform as the only FDA-approved CMI on the U.S. market, calling it “highly complementary” to its own portfolio of knee treatments. Read more
3. FDA approves Medtronic’s Enlite continuous glucose sensor
Medtronic said today that the FDA approved its Enlite sensor for the iPro2 Professional continuous glucose monitor.
Medtronic said the Enlite device, a disposable sensor designed to be worn for 6 days, is 69% smaller than its previous sensor. The iPro2 Professional system is designed to track glucose levels every 5 minutes, 24 hours a day, for as long as 6 days to help doctors gauge the effectiveness of nutrition, medication and exercise programs. Read more
2. Judge lifts bail, travel restrictions on ex-Acclarent execs
A federal judge in Boston this week lifted the bail and travel restrictions imposed on a pair of former Acclarent executives who were acquitted of felony fraud charges in July.
Former CEO William Facteau and ex-sales vice president Patrick Fabian were convicted on 10 misdemeanor counts of “introducing adulterated and misbranded medical devices into interstate commerce.” Facteau is now chairman, president & CEO of EarLens; Fabian hired on as chief commercial officer at NxThera in 2014, but is no longer listed in the executive roster on the company’s website. Read more
1. Alere airs dirty laundry in Abbott lawsuit
Abbott is deliberately stalling with federal anti-trust regulators, hoping to snuff the pending, $5.8 billion buyout of Alere, according to a lawsuit unveiled this week in a Delaware state court.
Waltham, Mass.-based Alere, which revealed the lawsuit last week, alleged that Abbott evaded a 2nd request for information on the tie-up from the Federal Trade Commission and accused CEO Miles White of threatening to make life a “living hell” for Alere if it didn’t walk away from the deal. Read more
The post MassDevice.com +5 | The top 5 medtech stories for September 1, 2016 appeared first on MassDevice.
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